EAY191-N4

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A Randomized Trial of Selumetinib and Olaparib or Selumetinib Alone in Patients with Recurrent or Persistent RAS Pathway Mutant Ovarian and Endometrial Cancers: A ComboMATCH Treatment Trial

Principal Investigator

Shannon Westin, MD

Status

Open to Accrual

Date Opened To Accrual

March 6, 2023


Disease Site

Gynecologic [GY] Multiple

Phase

II

Developmental Therapeutics

No

Primary Objective

Cohort I: Compare progression free survival of combination of olaparib and selumetinib to selumetinib alone in patients with RAS mutant ovarian cancer.
Cohort 2: Compare progression free survival of combination of olaparib and selumetinib to selumetinib alone in patients with RAS mutant endometrial cancer.

 

Patient Population

RAS pathway mutations as determined by the ComboMATCH screening assessment. Measurable and biopsiable disease as defined by RECIST 1.1.  Patients must have progressed after first-line treatment for recurrent or persistent disease.  Patients with ovarian cancer should not be eligible for further platinum-based therapy. Patients with endometrial cancer must have received or been offered an immune oncology agent (alone or in combination with lenvatinib) unless there are existing contraindications for immune oncology agents or lenvatinib.  Patients may have received unlimited prior therapy.

Target Accrual

165

Patient Study Webpage

To learn more about this study, visit the Patient Study Webpage.